NL-OMON37453已完成不适用
RAndomized comParison between the STENTYS self-aPpOSIng Sirolimus-eluting Coronary STent and a balloon-expandable stent In AcuTe MyocardIal InfarctiON - Apposition IV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Stentys
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged between 18 and 80 years.
- •2. Patients with ST-elevation myocardial infarction in the ambulance or in the cathlab >= 0.2 mV of ST-segment elevation in at least two consecutive leads, <12 hours after the onset of symptoms for >= 20 min
- •3. Target lesion is a de novo lesion
- •4. Signed authorization for informed patients
- •Angiography:
- •5. Diameter of the vessel is between 2.5 and 4.0mm corresponding to the available STENTYS and Resolute stent sizes (by visual assessment).
- •6. Target lesion <= 25mm in length (visual assessment).
排除标准
- •1. Pregnant women or nursing woman or woman of childbearing age without adequate contraception
- •2. Participation in another clinical study that the primary endpoint has not yet reached, or which interferes with the current study endpoints.
- •3. Coronary intervention or cardiac or major surgery <30 days ago.
- •4. Target vessel is a blood vessel that has a bypass.
- •5. Patient using Coumadin
- •6. Known hypersensitivity to aspirin, clopidogrel, heparin, stainless steel, sirolimus, Zotarolimus, contrast material.
- •7. Known thrombocytopenia (PLT <100,000 / mm3).
- •8. Active bleeding or coagulopathy or chronic anticoagulant therapy
- •9. Cardiogenic shock
- •10. Elective surgery and that discontinuation of dual antiplatelet therapy (DAPT) therapy is required.
- •11. Significant comorbidity which have the probability of non-compliance to clinical follow-up or affect the scientific integrity of the research (as judged by the investigator).
- •12. Left ventricular ejection fraction (LVEF) <30%.
- •13. Stroke or TIA within the last 6 months.;Angiography:
- •14. Severely tortuous, calcified or angulated coronary anatomy of the target vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complications from the placement of an OCT catheter.
- •15. Myocardial infarction due to stent thrombosis or infarction lesion in a previously stented coronary artery.
- •16. Unprotected left main stenosis> 30% (visual assessment)
- •17. Patients with significant lesions in two coronary arteries that require additional treatment within 30 days.
- •18. Patients with significant lesions in all three coronary arteries
- •19. Target lesion is a chronic total occlusion
- •20. Perforated drum, demonstrated by leakage of contrast.
- •21. Aneurysmal dilation, proximal or distal to the lesion
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